Evidence map›Paper›PMID 34579768›Full record

ArticleTrials2021

Natural vs. programmed cycles for frozen embryo transfer: study protocol for an investigator-initiated, randomized, controlled, multicenter clinical trial.

Sheriza Baksh, Anne Casper, Mindy S Christianson, Kate Devine, Kevin J Doody, Stephan Ehrhardt, Karl R Hansen, Ruth B Lathi, Fatmata Timbo, Rebecca Usadi and 5 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.3field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04551807 phase3active not recruitingnot on this map

Multi-center, Parallel-group, Randomized Controlled Trial of Modified Natural Versus Programmed Cycles for Frozen Embryo Transfers and Their Association With Preeclampsia and Live Births

TypeinterventionalSponsorJHSPH Center for Clinical TrialsRan2020 to 2026Enrolled788ConditionsPregnancy Related, Pre-EclampsiaArmsModified natural cycle, Programmed cycle
NCT05716139 naterminatednot on this mapstarted 2023, after this paper: background citation

Preeclampsia Following Natural vs. Artificial Cycle Frozen Embryo Transfer

TypeinterventionalSponsorIndira IVF Hospital Pvt LtdRan2023 to 2024Enrolled172ConditionsInfertility, Frozen Embryo Transfer, Preeclampsia and EclampsiaArmsNatural Cycle, Artificial Cycle
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 25 citations in OpenAlex.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 1 country.

Sheriza BakshDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 415 N. Washington Street, 2nd Floor, Baltimore, MD, 21231, USA. sbaksh4@jhu.edu.ORCID http://orcid.org/0000-0002-8341-860X
Anne CasperCenter for Clinical Trials and Evidence Synthesis, Johns Hopkins University, Baltimore, MD, 21205, USA.
Mindy S ChristiansonDivision of Reproductive Endocrinology and Infertility, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA.
Kate DevineShady Grove Fertility, Washington, DC, 20006, USA.
Kevin J DoodyCARE Fertility, Bedford, TX, 76022, USA.
Stephan EhrhardtDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 415 N. Washington Street, 2nd Floor, Baltimore, MD, 21231, USA.
Karl R HansenSection of Reproductive Endocrinoloogy and Infertility, Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK, 73104, USA.
Ruth B LathiDepartment of Obstetrics and Gynecology, Stanford University Medical Center, Sunnyvale, CA, 94087, USA.
Fatmata TimboCenter for Clinical Trials and Evidence Synthesis, Johns Hopkins University, Baltimore, MD, 21205, USA.
Rebecca UsadiAtrium Health, Charlotte, NC, 28203, USA.
Wendy VitekUniversity of Rochester Medical Center, Rochester, NY, 14642, USA.
David M ShadeDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 415 N. Washington Street, 2nd Floor, Baltimore, MD, 21231, USA.
James SegarsDivision of Reproductive Endocrinology and Infertility, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA.
Valerie L BakerDivision of Reproductive Endocrinology and Infertility, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, MD, 21205, USA.
NatPro Study Group
Johns Hopkins University · USAtrium Medical Cente · USCARE Fertility · USShady Grove Fertility Center · USStanford Medicine · USUniversity of Oklahoma · USUniversity of Rochester Medical Center · US

Funding

1/3 A randomized controlled trial of frozen embryo transfers performed in modified natural versus programmed cycles (NatPro)R01HD100341 · NICHD · JOHNS HOPKINS UNIVERSITY · PI BAKER, VALERIE LYNN, SEGARS, JAMES H. · 2019 to 2023
$9.3M
3/3- A randomized controlled trial of frozen embryo transfers performed in modified natural versus programmed cycles (NatPro)R01HD100334 · NICHD · STANFORD UNIVERSITY · PI LATHI, RUTH B, WINN, VIRGINIA D · 2019 to 2023
$1.6M
2/3 A randomized controlled trial of frozen embryo transfers performed in modified natural versus programmed cycles (NatPro)R01HD100305 · NICHD · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI HANSEN, KARL RICHARD · 2019 to 2023
$1.5M
National Institute of Child Health and Human Development R01HD100305National Institute of Child Health and Human Development R01HD100334National Institute of Child Health and Human Development R01HD100341NICHD NIH HHS R01 HD100305NICHD NIH HHS R01 HD100334NICHD NIH HHS R01 HD100341
6 · The paper itself

Abstract

backgroundRandomized trials of assisted reproductive technology (ART) have been designed for outcomes of clinical pregnancy or live birth and have not been powered for obstetric outcomes such as preeclampsia, critical for maternal and fetal health. ART increasingly involves frozen embryo transfer (FET). Although there are advantages of FET, multiple studies have shown that risk of preeclampsia is increased with FET compared with fresh embryo transfer, and the reason for this difference is not clear. NatPro will compare the proportion of preeclampsia between two commonly used protocols for FET,modified natural and programmed cycle.

methodsIn this two-arm, parallel-group, multi-center randomized trial, NatPro will randomize 788 women to either modified natural or programmed FET and follow them for up to three FET cycles. Primary outcome will be the proportion of preeclampsia in women with a viable pregnancy assigned to a modified natural cycle FET (corpus luteum present) protocol compared to the proportion of preeclampsia in pregnant women assigned to a programmed FET (corpus luteum absent) protocol. Secondary outcomes will compare the proportion of live births and the proportion of preeclampsia with severe features between the protocols.

conclusionThis study has a potential significant impact on millions of women who pursue ART to build their families. NatPro is designed to provide clinically relevant guidance to inform patients and clinicians regarding maternal risk with programmed and modified natural cycle FET protocols. This study will also provide accurate point estimates regarding the likelihood of live birth with programmed and modified natural cycle FET.

trial registrationClinicalTrials.gov NCT04551807 . Registered on September 16, 2020.

Indexed as

CryopreservationEmbryo TransferFemaleHumansLive BirthMulticenter Studies as TopicPregnancyPregnancy RateRandomized Controlled Trials as TopicReproductive Techniques, AssistedRetrospective StudiesFrozen-thawed embryo transferModified natural cyclePreeclampsiaProgrammed cycle

Identifiers

PMID34579768
PMCPMC8477459
OpenAlexW3204868845

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.